Best Practices for Developing Requirements for FDA-Regulated Systems - PowerPoint PPT Presentation

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Best Practices for Developing Requirements for FDA-Regulated Systems


This course will provide specific guidelines to attendees on the best practices for developing requirements for computer systems regulated by the FDA. – PowerPoint PPT presentation

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Title: Best Practices for Developing Requirements for FDA-Regulated Systems

FDA computer system validation FDA regulation
  • Best Practices for Developing Requirements for
    FDA-Regulated Systems

Carolyn Troiano
Computer system validation has been
regulated by the FDA for more than 30 years, as
it relates to systems used in the manufacture,
testing, distribution and management of a product
in the pharmaceutical, biotechnology, medical
device, animal health, tobacco and other
regulated industries. The
requirements phase of the SDLC is a key aspect of
computer system activities that must adhere to
the FDA guidelines. As such, there are specific
deliverables and tasks that must be completed and
appropriately documented. There are best
practices associated with vendor management
methodologies used in the FDA-regulated arena,
and these can be leveraged to develop a standard
and consistent approach within a company. 
Why Should you Attend
  • The attendee will learn
    how to develop a standard approach to managing
    the requirements process in a manner that
    complies with FDA guidelines for computer
    systems. Some of these people will be new to the
    concept of validation and FDA regulation, and
    will have to be coached on how to follow any
    necessary procedures required for compliance.
    There is an enormous body of
    documentation and information available that can
    be overwhelming. This course will provide a
    condensed overview of the practices that deliver
    the best results by directing the attendees to
    the most critical and cost-effective techniques
    and tools available to assure compliance when
    managing requirements-related activities. 

Objectives of the Presentation
  • The course will focus on the
    key aspects of requirements development and
    management, including best practices and
    principles for handling this key component of
    project work in an FDA-regulated environment
    (i.e., the system "touches" product during the
    manufacturing, testing or distribution of the
    product, or during any other functional

Who can Benefit
Information technology analysts, project
managers, organizational change managers,
business process engineers, QC/QA managers and
analysts, clinical data managers and scientists,
analytical chemists, compliance managers, lab
managers, automation analysts, computer system
validation specialists, GxP training specialists,
business stakeholders and individuals who are
responsible for computer system validation
planning, execution, testing, reporting,
compliance, and audit.
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